January 8, 2019

FDA Pre-Cert Pilot Program to promote more efficient review of digital health innovations

By: Judy Mathias

Editor’s Note

The Food and Drug Administration (FDA) on January 7 issued a statement from Commissioner Scott Gottlieb, MD, on the agency’s new actions under the Digital Health Pre-Certification (Pre-Cert) Pilot Program to promote a more efficient framework for the review of safe and effective digital health innovations.

Because digital tools, such as artificial intelligence software that can alert physicians to a potential stroke and smart watches that can identify atrial fibrillation, are rapidly evolving, the FDA must modernize its approach to regulation, notes Dr Gottlieb.

The program will help make sure patients continue to have access to new treatment that meet the FDA gold standard for safety and effectiveness, he says.


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